An Analysis Of FDA FY2016 Drug GMP Warning Letters

The
number of drug GMP warning letters issued more than doubled over the previous
year, from 42 in FY2015 to 102 in FY2016.

The
compounding pharmacy/outsourcing facility segment continues to attract
disproportionate enforcement attention from FDA, receiving more than 50% of the
warning letters for the third fiscal year in a row. This suggests that firms
are not learning from the enforcement actions taken against others.

The
number of warning letters issued to API manufacturers and dosage manufacturers
is approximately equal in FY2016, with a dramatic increase in the number of
warning letters issued to API manufacturers over those issued in FY2015.

Excluding
the compounding pharmacies and outsourcing facilities, FDA continues to focus
enforcement actions outside the U.S. (OUS), where most generic drugs are
produced. Over three times as many warning letters were issued to OUS firms
compared to domestic firms. Firms in India and China received 71% of the
warning letters issued to firms outside the U.S. Warning letters issued to
sites in China increased from two in FY2015 to 15 in FY2016.

The
percent of warning letters that cite deficiencies in data integrity remains
consistent at approximately 80% for OUS firms and reaches the same percentage
for warning letters issued to sites in the U.S. in FY2016. This year saw a
significant increase for U.S. warning letters citing data integrity
deficiencies.

Import
alerts were associated with 17 of the 35 warning letters issued to OUS sites in
FY2016. Firms in China and India that received warning letters were the subject
of 15 of the 17 import alerts associated with warning letters.

The
interval between inspection and issuance of warning letters has increased over
the past four fiscal years. When import alerts were put in place, they
generally occurred in half the time required to issue the associated warning
letter.